Systems, devices, and methods for treating pelvic floor disorders

• US 20060229596A1
• Filed: 04/06/2006
• Published: 10/12/2006
• Est. Priority Date: 04/06/2005
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Chu, Michael S. H., Nowlin, Brett, Weiser, Michael F., Mamo, George
• Application Number:
  US11/400,111
• Publication Number:
  US 20060229596A1
• Time in Patent Office: Days
• US Class Current: 606/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30617 : Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/005 : differing in colour
• CPC Class Codes: A61F 2250/0087 : colour-coded
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia

Abstract

Disclosed are single-incision surgical procedures for treatment of urinary incontinence and/or pelvic floor disorders and related uses, devices, kits, and methods. Implants are also disclosed for use in the exemplary procedures. In certain embodiments, soft tissue anchors are used to anchor the surgical implants to obturator membranes of a patient.

Claims

1. A surgical implant assembly for pelvic floor repair of a patient, comprising

a surgical implant having a first end adapted to extend to a first obturator membrane of the patient, a second end adapted to extend to a second obturator membrane of the patient, and a central region adapted to extend at least posterior to the bladderneck of the patient;

and

first and second soft tissue anchors coupled to respective ones of the first and second ends of the surgical implant for securing the first and second ends to respective first and second obturator membranes.

2. The assembly of claim 1, wherein the central region is sized and shaped for supporting the base of the bladder of the patient.

3. The assembly of claim 1, wherein the implant has a maximum anterior-to-posterior width of greater than about 4 cm.

4. The assembly of claim 1, wherein the implant has a lateral width less than about three times an anterior-to-posterior width of the implant.

5. The assembly of claim 1, wherein the central region is circular.

6. The assembly of claim 1, wherein the first soft tissue anchor comprises an elongated body having an aperture in a proximal end and a passage extending axially in a distal direction at least part way to a distal end of the elongated body, and a plurality of barbs projecting from an outer surface of the elongated body.

7. The assembly of claim 1, wherein the first soft tissue anchor has a smooth outer surface.

8. The assembly of claim 7, wherein the first soft tissue anchor comprises an elongated body having an aperture in a proximal end and a passage extending axially in a distal direction at least part way to a distal end of the elongated body.

9. The assembly of claim 1, wherein the implant includes at least one tanged portion.

10. The assembly of claim 1, wherein the first soft tissue anchor is bioabsorbable.

11. The assembly of claim 1, wherein the first soft tissue anchor couples to the sling by a filament.

12. The assembly of claim 11, wherein the filament has sufficient length to space the first soft tissue anchor apart from the implant.

13. The assembly of claim 12, wherein the filament comprises an adjustable size loop to vary a space between the first soft tissue anchor and the implant.

14. The assembly of claim 1, wherein the first soft tissue anchor physically contacts the implant, and the orientation of the implant with respect to the soft tissue anchor is adjustable.

15. A surgical implant assembly for pelvic floor repair of a patient, comprising

an implant for extending at least partially between a first obturator membrane and a second obturator membrane of a patient, and having a first strap end for aligning with the first obturator membrane and a second strap end for aligning with the second obturator membrane;

and

a first plurality of soft tissue anchors coupled to the first strap end of the implant for securing the first strap end to a first soft tissue region, and

a second plurality of soft tissue anchors coupled to the second strap end of the implant for securing the second strap end to a second soft tissue region.

16. The assembly of claim 15, wherein the first plurality of soft tissue anchors secure the first strap end to the first obturator membrane, and the second plurality of soft tissue anchors secure the second strap end to the second obturator membrane.

17. The assembly of claim 16, wherein the first plurality of soft tissue anchors comprises at least three soft tissue anchors, and the second plurality of soft tissue anchors comprises at least three soft tissue anchors.

18. A method for implanting a surgical implant in the pelvic floor region of a patient comprising

creating an incision in the vaginal wall of the patient,

coupling the implant to a delivery device,

inserting the delivery device through the vaginal incision via the external vaginal opening of the patient to extend a portion of the implant to an anatomical location posterior to the bladder neck of the patient, and

guiding the device to a location beneath the patient'"'"'s epidermis to secure the implant in the patient'"'"'s soft tissue.

19. The method of claim 18, comprising securing a first end of the implant to a first obturator membrane, and securing a second end of the implant to a second obturator membrane.

20. The method of claim 18, comprising

coupling a first soft tissue anchor to a first end of the implant,

coupling a second soft tissue anchor to a second end of the implant, and

anchoring the first and second soft tissue anchors to respective obturator membranes.

21. The method of claim 20, comprising adjusting the tension of the implant by extending or retracting a portion of at least one of the first end and the second end of the implant through the respective obturator membranes.

22. The method of claim 20, comprising

coupling the first soft tissue anchor to the first end of the implant by threading a filament through the first soft tissue anchor and the implant,

cinching the filament into a loop with a first slidable filament locking element,

coupling the second soft tissue anchor to the second end of the implant by threading a filament through the second soft tissue anchor and the implant, and

cinching the filament into a loop with a second slidable filament locking element.

23. The method of claim 22, further comprising tensioning the implant by sliding at least one of the first filament locking element and the second filament locking element towards a respective one of the first soft tissue anchor and the second soft tissue anchor, thereby drawing a respective one of the first end and the second end of the implant towards the respective one of the first soft tissue anchor and the second soft tissue anchor.

24. The method of claim 18, wherein inserting the delivery device through the vaginal incision via the external vaginal opening of the patient comprises

coupling the implant to a delivery device having a shaft and a slidable cannula disposed about the shaft,

inserting the delivery device through the external vaginal opening,

guiding the delivery device through the vaginal incision subsequent to inserting the delivery device through the external vaginal opening,

aligning the shaft with a first obturator membrane,

sliding the cannula distally along the shaft, and

securing the implant to the first obturator membrane.

25. The method of claim 18, wherein coupling the implant to the delivery device includes coupling the implant to at least soft tissue anchor, and coupling the soft tissue anchor to a shaft of the delivery device.

26. The method of claim 25, further comprising

creating an aperture in an obturator membrane, and

driving the soft tissue anchor through the aperture.

27. The method of claim 18, wherein securing the implant comprises

coupling a first plurality of soft tissue anchors to a first end of the implant,

coupling a second plurality of soft tissue anchors to a second end of the implant,

anchoring the first plurality of soft tissue anchors to a first obturator membrane, and

anchoring the second plurality of soft tissue anchors to a second obturator membrane.

28. The method of claim 18, wherein the implant has at least one tanged portion.

29. The method of claim 18, wherein the implant has a plurality of soft tissue anchors on a first end of the implant.

30. The method of claim 18, comprising securing the mesh to one or both of the sacrospinous ligament and levator ani muscle.

31. A surgical implant assembly for pelvic floor repair of a patient, comprising

a surgical implant having a first end, a second end, and a central region adapted to extend to a position posterior to the bladderneck of the patient;

and

at least one soft tissue anchor coupled to an end of the surgical implant and adapted to secure the implant within the patient'"'"'s pelvic floor.

32. The assembly of claim 31, wherein the central region is sized and shaped for supporting the base of the bladder of the patient.

33. The assembly of claim 31, wherein the implant has a lateral width less than about three times an anterior-to-posterior width of the implant.

34. The assembly of claim 31, wherein the first end is adapted to extend to a first obturator membrane of the patient, and the second end is adapted to extend to a second obturator membrane of the patient.

35. The assembly of claim 31, wherein the at least one soft tissue anchor comprises an elongated body having an aperture in a proximal end and a passage extending axially in a distal direction at least part way to a distal end of the elongated body, and a plurality of barbs projecting from an outer surface of the elongated body.

36. The assembly of claim 31, wherein the implant includes at least one tanged portion.

37. The assembly of claim 31, wherein the at least one soft tissue anchor is bioabsorbable.

38. The assembly of claim 31, wherein the at least one soft tissue anchor couples to the sling by a filament.